Christine B.

Professional background

Associate Director of Quality Operations at a biotechnology company. I have 12 years of experience in the biopharmaceutical industry with small and large companies in cell therapy and biologics. Experience in manufacturing and quality, maturing documentation and processes for companies moving from clinical to commercial launch. I have personal interests/expertise in the areas of residential real estate and fitness.

Fachgebiete

Areas of expertise include change control, deviations, CAPAs, document management, GMP training, risk management, supplier management, audits & inspections, quality agreements, lot disposition, management review, computerized systems, and the latest topics of data integrity, metrics, and quality culture. I've performed audits of quality systems and participated in FDA and EMA regulatory inspections.